Food and Drug Administration, also known as FDA, is something to be reckoned with when talking about importing into the US. As the guardian of the safety of foods and drugs and monitor of the performance of other products, FDA has imposed stringent requirements for specific products shipped into this country. Anything showing non-compliance will be rejected for interstate commercial distribution.
So you do see the role that FDA plays in importing to the US. Indeed, the FDA also manages domestically manufactured products that fall into the category of human consumption. This article will focus on imports into the US since they are vitally interrelated with freight shipping industry. We will give you an overview of FDA regulations, hoping to smooth your FDA approval and registration process. If you engage in foreign trade targeting the US or you are a first timer learning about the FDA, read on.
As a government agency, FDA is built within the US Department of Health and Human Services. Essentially, it is incumbent on this authority to protect public health and ensure the public has a continued supply of safe foods and drugs.
Sounded like a herculean task. To break it down, FDA is responsible for regulating and supervising a myriad of products both manufactured domestically and imported into the US. It has implemented a series of regulations for those who are involved in cargo transportation and importing. Industry insiders have to demonstrate compliance with these regulations.
Understanding the responsibility of the FDA can help entrepreneurs get the hang of the reason behind the FDA regulatory regimes. Before you can actually enjoy the exciting opportunities brought by foreign trade, you should strictly abide by the FDA standards first.
Not all the products imported into the US are under FDA jurisdiction. In this part, we will specify what on earth the FDA oversees, namely the FDA-regulated products.
The regulatory requirements differ based on the specific nature of your products. For example, cosmetics can enter the market with no prior approval. In contrast, new food additives and color additives must get approved by the FDA before being put into products.
Please remember that FDA is an executive department, which means it has the right to refuse admission into the US and seize sub-standard products. So be careful.
The following list shows product categories that should represent adherence to the FDA regulatory laws. The list may not be all-inclusive. You can find more detailed information via the FDA official website.
● dietary or nutritional supplements
● bottled water
● food additives
● food ingredients
● infant formulas
● seafood products
● fresh produce: fruits and vegetables
● dairy products: cheeses, yogurt, and milk products
● beverages: fruit and vegetable juices, carbonated drinks, and energy drinks
● processed food: dry foods, canned foods, acidified foods, and prepared meals
● Items such as meat (beef, lamb, and pork), poultry, certain processed egg products, and catfish are regulated exclusively by the US Department of Agriculture (USDA), not the FDA.
● In order to get permission for sale, foods upon arrival in the US need to carry the FDA approval or undergo the pre-market review, depending on the specific materials used. Make sure you figure out which needs what and make meticulous preparation.
● Some special regulations will apply to canned foods. Importers are required to submit to FDA with a Scheduled Process Identification (SID) filing form and keep the form updated. Without SID Number compliance, it is hard for the regulator to wave them through.
● prescription drugs
● over-the-counter drugs
● FDA has jurisdiction over all prescription and over-the-counter drugs distributed in the US market.
● The intensity of regulations applied to drugs depends on their types. For example, OTC monographs will comply with less strict requirements.
● Harmful color additives, Mercury compounds, Bithionol, and Chloroform are restricted by the FDA. Products containing the above substances will be denied entry into the US unless there is a prior notice or proper certification.
● Sometimes, what belongs to which category may stir up confusion. For example, acne-treatment makeup, antiperspirant deodorant, and cavity-fighting toothpaste are considered borderline products. They combine the function of cleansing or beautifying with the role of mitigation, prevention, or treatment of a disease, blurring the definition of drugs and cosmetics. Traditionally they are viewed as cosmetics, but they can also fit into the “drug” category by the FDA standards.
● Imported drug shipments really call for special attention. Drugs not in compliance with FDA regulations or from unregistered establishments will be refused admission or subject to detention.
● simple items such as tongue depressors, bedpans, and more
● complex technologies such as heart pacemakers
● dental devices
● surgical implants and prosthetics
● What you may find as unexpected is that sunglasses, lens frames, spectacle lenses, and magnifying glasses all fall into the category of medical devices. Another thing to mention, they can escape submission to the FDA because of the Premarket Notification 510(k).
● In order to better inspect medical devices, FDA has exercised category-based regulation. Medical devices are classified into three categories based on the potential risks they carry. Different classifications will abide by different regulations.
● Radiation-emitting devices designed for medical use will be classified as “medical devices” by the FDA standards.
● microwave ovens
● X-ray equipment
● laser products
● ultrasonic therapy equipment
● ultrasonic instrument cleaners
● mercury vapor lamps
● infrared and ultraviolet devices
● ultrasound machines
● welding equipment
● alarm system
● All electronic devices that emit radiation will conform to the FDA regulatory regime. It may never enter your mind that television receivers actually fall under the jurisdiction of the FDA as one of the radiation-emitting products. Anyway, it does. The same goes with computer monitors, blacklight sources, electron microscopes, DVD players, and CD players.
VACCINES, BLOOD, AND BIOLOGICS
● vaccines for humans
● blood and blood products
● cellular and gene therapy products
● tissue and tissue products
● FDA is NOT responsible for ensuring the safety and efficacy of vaccines intended for animal diseases.
● color additives used in makeup and other personal care products
● skin moisturizers and cleansers
● nail polish
● Not all cosmetics need FDA approval. As long as it does not contain the forbidden color additives, it can be imported smoothly. Cosmetics are actually one of the safest products imported into the US, so the FDA has loosened its regulation.
● cigarette tobacco
● roll-your-own tobacco
● smokeless tobacco
ANIMAL AND VETERINARY
● livestock feeds
● pet foods
● veterinary drugs and devices
3.1 FDA Documentation Review
The FDA review process is a must for all the FDA-regulated items introduced into the US. The US Customs and Border Patrol (CBP) will send the submitted entries to FDA for undergoing review. It is worth noting that inaccurate and inadequate information will incur further manual review, prolonging the process. So you should make sure the information provided reveals full accuracy.
What is needed to submit to FDA for review?
● Packing list
● Commercial invoice
● Commodity-specific certifications
● Documentation stating manufacturer & importer information
What will the FDA officials do during the review process? They will check the compliance history of the importer to see whether the materials used in their items get regulatory approval and then decide whether to give a green-light.
3.2 FDA Registration Review
“FDA registered” means that the FDA is aware of the existence of this producing facility, while their products are yet to be assessed or tested. FDA is provided with the authority to conduct facility inspections to ensure that products can meet their mandatory safety standards.
In regard to importing, foreign establishments need to register with the FDA in advance in order to get a prior permission. To be more specific, the manufacturer and the importer must register their establishments with the FDA.
Based on the different activities performed at the establishments, the requirements for registration vary widely. It is not mandated that all types of establishments have to do the registration. For example, cosmetic manufacturers already have the incentive to meet higher standards for fear of the “loss of goodwill,” so the relevant facilities can skip the registration process with the FDA.
Registration with FDA needs to be renewed annually. FDA will review all the provided information for a given facility and its associated device listing.
Online registration can be done via the FDA official website now. We will show you what information is essential in the registration process, taking one food facility for example:
● Type of Registration
● Facility Name/Address
● Parent Company Name/Address
● Trade Names
● United States Agent
● Owner, Operator, or Agent in Charge
● General Product Categories
But you can also designate a US FDA agent for the registration. So you do not have to do the communication yourself.
FDA Approval can sometimes stump the outsiders. First, what products are required to get approved by FDA? Second, how do these products gain FDA approval? Last, what does the FDA approval process look like? Hang on, if you are new to the FDA regulatory system, you may find yourself at a loss. No worries. We have already gathered some key information for you.
Regular foods, beverages, and dietary supplements do not need FDA approval. However, the FDA has established a pre-market approval system for new food additives. That means new food additives will undergo a testing process before the intended products enter distribution in the US. As for pet food, there is no need to get pre-market approval for pet food under FDA regulations. However, it is stated that all pet foods should be without harmful food additives and color additives.
FDA approves new drugs. However, it is also worth noting that when one type of drugs proves to conform to the OTC monograph requirements, it can be placed on the market without FDA approval.
As we mentioned before, all FDA-regulated medical devices can be put into three classifications. Class Three carries the highest potential risk, so FDA approval is required.
Unlike the regulation of other products, cosmetics are not subject to pre-market FDA approval. But in some cases, a cosmetic may fall into the “drug” category by the FDA standard. Consequently, FDA approval is required.
Color Additives, often used in foods, drugs, cosmetics, and medical devices, are subject to a rigorous FDA regulatory system. So products containing color additives call for special attention. It is mandated that color additives should receive either the batch certification or the exemption from the certification. Every shipment will be examined to see whether it contains unapproved color additives. So color additives must secure FDA approval for a smooth entry into the US.
How do products get approved by FDA? Simply put, the FDA will review and examine all the data submitted by the product manufacturer to ensure safety and efficacy. Products that prove to meet the relevant standards can receive FDA approval. It is an arduous process, causing time and energy. When you submit all the documentation, it may take months to get an official determination.
It can be hard to navigate all the procedures when importing into the US. Being unfamiliar with the registration and approval process may lead to undesirable costs and an inhibited trade flow. Sometimes manufacturers and suppliers could even be held liable for failing to fulfill the state-imposed duty.
We hope this article can clear up your confusion regarding FDA regulations and requirements. It is in everyone’s interest that commerce between states remains unhindered.
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